Guidelines Coming to Counter Stem Cell “Snake Oil” Treatment Claims

The researchers told a news conference they hope the standards, which are still being written, will shape research and also let the average patient know what is and what is not available.

As reported by Maggie Fox, Reuters Health and Science Editor, some unethical Web sites and clinics are offering "snake oil" treatments that claim to provide cures using stem cells but are at best raising false hopes, stem cell experts said. The International Society for Stem Cell Research (ISSCR) said it wants to counter these misleading claims with a set of guidelines for researchers and the public alike, in part to preserve the reputation of the field.

"These guidelines are critically important to the future success of the field," said Dr. George Daley, president of the group and a stem cell researcher at Children's Hospital and Harvard Medical School in Boston.

"Not only does the use of untested therapies put patients at risk, it jeopardizes the legitimate practice of all translational stem cell research."

The group declined to name any Web site or clinic but said they are widely advertised. Daley said a recent Internet search turned up a number of sites offering stem cell cures.

"They are basically selling the snake oil that we have seen for centuries," he said. "People are offering miracle cures for real medical conditions. So in part to act against that ... the ISSCR felt the need to respond."

The Web sites say they "can cure any disease you can find in a pathology textbook," said Dr. Giulio Cossu, a stem cell expert at the San Raffaele Institute in Milan, Italy.

The researchers told a news conference they hope the standards, which are still being written, will shape research and also let the average patient know what is and what is not available.

"There are extremely high levels of hope and hype and extremely high levels of uncertainty and risk," said Laurie Zoloth, a professor of medical ethics at Northwestern University in Chicago.

"With all the hype there is a risk that patients who are desperate will misunderstand the true level of advancement," Daley said. "They will assume that the cures are already here today or just around the corner."

Stem cells are the body's master cells and they come in a wide range of forms, from the cells in bone marrow that are widely used to treat cancer and other conditions, to embryonic stem cells -- those that give rise to all the cell types in the body.

The field has received intense attention, in part because it carries the promise of tailored treatments and truly regenerative medicine that might transform treatment of diseases such as Parkinson's, as well as catastrophic injuries.

The field has also been sullied by scandal, notably the case of disgraced South Korean researcher Hwang Woo-Suk, who admitted in 2006 to fabricating data to support claims he had made the first human embryos using cloning technology and then derived stem cells from them.

The experts all noted that there are very few legitimate stem cell treatments available now except for blood disorders such as leukemia and immune deficiencies. The proposed new guidelines will condemn the use of stem cell therapies outside of an established clinical trial. They will seek to use guidelines drawn up by various countries, including the U.S. Food and Drug Administration and the European regulators, but also from Japan, India, and elsewhere. The guidelines make specific recommendations for ethical oversight, peer review of studies, informed consent, and protection of volunteers, but also address social justice issues such as access to the treatments.